NCT03825289

Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer

THREAD: A Phase I Trial of Trametinib and Hydroxychloroquine in Patients With Advanced Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the sides effects and best dose of hydroxychloroquine when given together with trametinib in treating patients with pancreatic cancer that has spread to nearby tissue, lymph nodes or other places in the body and cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib together with hydroxychloroquine may work better in treating patients with pancreatic cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommended phase II dose of hydroxychloroquine in combination with trametinib as assessed by the occurrence of dose-limiting toxicities (DLTs).

Conditions

• Metastatic Pancreatic Carcinoma
• Stage II Pancreatic Cancer
• Stage IIA Pancreatic Cancer
• Stage IIB Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer
• Unresectable Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Given PO
DRUG	Trametinib	Given PO

Timeline

• Start date: 2019-01-18
• Primary completion: 2025-01-15
• Completion: 2029-03-01
• First posted: 2019-01-31
• Last updated: 2025-04-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study